module 5. medicines for preventive chemotherapy: … · • mohs are invited to submit the jap...

PROGRAMME MANAGERS’ TRAINING COURSE FOR NTDS TARGETED FOR CONTROL OR ELIMINATION BY PREVENTIVE CHEMOTHERAPY INTERVENTIONS


Module 5. Medicines for Preventive Chemotherapy:Planning, Applying, Managing, Reporting

Sessions 1 & 2. Joint Application Package (JAP)

and Drug Supply Chain (DSC) Management


Module 5. Medicines for Preventive ChemotherapySessions 1 & 2. Joint Application Package (JAP) and

Drug Supply Chain (DSC) Management

PART 1. JOINT APPLICATION PACKAGE (JAP)

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How many forms does the JAP include?

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Joint Application Package

• A tool designed to facilitate integrated planning, implementation, M&E, and reporting of preventive chemotherapy interventions. It includes:

– Joint Request for Selected PC Medicines (ALB, MEB, PZQ, DEC)

– Joint Reporting Form (ALB, MEB, PZQ, DEC)

– Annual Work Plan (activities, timeline, costs…)

– PC Epidemiological Data Reporting Form

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ENGLISH: http://www.who.int/neglected_diseases/preventive_chemotherapy/reporting/en/index.htmlFRANÇAIS: http://www.who.int/neglected_diseases/preventive_chemotherapy/reporting/fr/index.htmlESPAÑOL: http://www.who.int/neglected_diseases/preventive_chemotherapy/reporting/es/index.html

INTRO

LF

ONCHO

STH

SCH

Non-endemic

Non-endemic

Non-endemic

Non-endemic

This worksheet includes guides how to complete the PC epidemiological data reporting form and

information about status of PC for endemic diseases in the country

This worksheet includes indicators to report epidemiological data on lymphatic filariasis and

section to report data on morbidity management and disability prevention

PC Epidemiological Data Reporting FormThe purpose of this template PC Epidemiological Data Reporting Form (PC EPIRF) - available as an Excel file -

is to provide national health authorities and data managers with a standardized tool to address these reporting

challenges, facilitate integration and thereby further contribute to improving overall programme management. This

template aims to standardize national reporting of epidemiological data on diseases targeted for preventive

chemotherapy, improve availability and coordination of preventive chemotherapy data across the World Health

Organization regions.

National authorities are requested to complete this form for submission to the World Health Organization on annual

basis. This form could be submitted with the PC Joint Reporting Form (JRF).

Structure of the application (worksheets):

Please enter your data into the cells according to their colour code:

White - cell is not protected. Please enter the value of the requested indicator.

This worksheet includes indicators to report epidemiological data on onchocerciasis

This worksheet includes indicators to report epidemiological data on schistosomiasis

Instruction for data entry

This worksheet includes indicators to report epidemiological data on soil-transmitted

helminthiases

Country data

Yellow - cell is protected and includes name of indicator. No data entry required.

Orange - cell is not protected and includes a drop-down menu. Please select the value from the

drop-down list.

Is country endemic for soil-transmitted helminthiases (STH)?

Is country endemic for schistosomiasis (SCH)?

COUNTRY

Year of reporting data

Green - cell is not protected and includes formula. Please change the value only if your data

are different from those that are calculated automatically.

Is country endemic for lymphatic filariasis (LF)?

Is country endemic for onchocerciasis (ONCHO)?

Blue - cell is protected and includes formula. No data entry required.

Snapshot of the Forms (Excel format)

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http://www.who.int/neglected_diseases/preventive_chemotherapy/reporting/en/index.html

http://www.who.int/neglected_diseases/preventive_chemotherapy/reporting/fr/index.html

http://www.who.int/neglected_diseases/preventive_chemotherapy/reporting/es/index.html




Joint PC Process at Global Level

National Programme/s

GSK Eisai J&J

ALB DEC MBD

Independent review group

e.g. RPRG

MerckKGaA

PZQ

SHIPMENT

Joint Request + Joint Report

+ Annual work plan+EPIRF

ORDER

AZI

ITIApplications

Shipments

WHO

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Joint Application Package

• MoHs are invited to submit the JAP electronically, once a year, via WHO CO, WHO RO and WHO HQ.

– Deadline for submission is 15 August – Request for the following year and Report for the previous year. (e.g. now Request for 2016 and

Report on 2014 treatment)

• Applications are reviewed by independent bodies, coordinated by the RO with support from WHO HQ.

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Requesting Medicines – JRSM

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Requesting Medicines - JRSM

• Countries are invited to express their 2016 national needs for the following medicines:– LF: DEC and ALB

– SCH: PZQ

– STH: ALB or MEB

• Countries should express their needs even if they already secured drug supply from sources other than WHO.– This is to improve coordination among all other donors/partners

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Requesting Medicines – JRSM Additional note on PZQ

• PZQ is currently donated only for SAC.

• However, countries that are willing to include adults in the target population of preventive chemotherapy interventions against schistosomiasis, are invited to express the relevant drug needs in the PZQ tab of the JRSM.

• Such request will not appear in the Summary tab, however it will help estimate global drug needs in view of the increased availability of PZQ from 2016 onwards.

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Reporting on Treatment - JRF

• The JRF should be used to report on any preventive chemotherapy interventionimplemented in 2014.– including the use of DEC, ALB, MEB or PZQ

– Including treatment data whatever the source of the medicines is (WHO or other partners or direct purchasing)

– data by sub-national level (e.g. district) for the ENTIRE COUNTRY

• Only treatment data should be included in JRF.– M&E data e.g. mapping SS/SC, morbidity data

and TAS results should be included in EPIRF

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Annual Work Plan (AWP)

• AWP (Excel table) should indicate the planned scheduleand funding situation of key PC activities during the year for which drugs are requested

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Epidemiological Data Reporting Form (EPIRF)

• Epidemiological Data Reporting Form (EPIRF) should indicate:– new mapping data completed recently

– M&E data (e.g. SS/SC survey results)

– TAS results>>> used to revise the estimates of population requiring PC

– morbidity-related data

INTRO

LF

ONCHO

STH

SCH

Non-endemic

Non-endemic

Non-endemic

Non-endemic

This worksheet includes guides how to complete the PC epidemiological data reporting form

and information about status of PC for endemic diseases in the country

This worksheet includes indicators to report epidemiological data on lymphatic filariasis and

section to report data on morbidity management and disability prevention

PC Epidemiological Data Reporting FormThe purpose of this template PC Epidemiological Data Reporting Form (PC EPIRF) - available as an Excel file -

is to provide national health authorities and data managers with a standardized tool to address these reporting

challenges, facilitate integration and thereby further contribute to improving overall programme management. This

template aims to standardize national reporting of epidemiological data on diseases targeted for preventive

chemotherapy, improve availability and coordination of preventive chemotherapy data across the World Health

Organization regions.

National authorities are requested to complete this form for submission to the World Health Organization on annual

basis. This form could be submitted with the PC Joint Reporting Form (JRF).

Structure of the application (worksheets):

This worksheet includes indicators to report epidemiological data on onchocerciasis

This worksheet includes indicators to report epidemiological data on schistosomiasis

Instruction for data entry

This worksheet includes indicators to report epidemiological data on soil-transmitted

helminthiases

Yellow - cell is protected and includes name of indicator. No data entry required.

Orange - cell is not protected and includes a drop-down menu. Please select the value from the

drop-down list.

Please enter your data into the cells according to their colour code:

White - cell is not protected. Please enter the value of the requested indicator.

Is country endemic for soil-transmitted helminthiases (STH)?

Is country endemic for schistosomiasis (SCH)?

COUNTRY

Year of reporting data

Green - cell is not protected and includes formula. Please change the value only if your data

are different from those that are calculated automatically.

Is country endemic for lymphatic filariasis (LF)?

Is country endemic for onchocerciasis (ONCHO)?

Blue - cell is protected and includes formula. No data entry required.

Country data

Name of evaluation unit

(for TAS only)

Name of

implementation unit

Name of

survey siteType of survey

Date of

survey

(month)

Latitude

(decimal)

Longitude

(decimal)

Date of the

first round

of MDA

(year)

Number of

MDA

rounds

completed

Number of

people

examined

Number of

people

positive

%

positive

Diagnostic

testAge range Survey site Survey type

# schools

or EA

targeted

Target

sample size

Number of

people

examined

Number of

people

positive

%

positive

Number of

invalid tests

Critical

cut-offDecision

Number of

people

examined

Number of

people

positive

%

positive

Number of

people

examined

Number of

people

positive

%

positive

Lymphoedema HydrocoeleAssessment surveys (mapping, sentinel sites, spot-check sites, and TAS) MF Ag/Ab

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Where Can I Find the Forms?

• All forms are available in English: http://www.who.int/neglected_diseases/preventive_chemotherapy/reporting/en/

• … in French: http://www.who.int/neglected_diseases/preventive_chemotherapy/reporting/fr/

• … and in Spanish: http://www.who.int/neglected_diseases/preventive_chemotherapy/reporting/es/

• A userguide on how to fill the forms is available (English only, currently being translated into Fr and Sp): http://apps.who.int/iris/bitstream/10665/83962/1/9789241505499_eng.pdf?ua=1

• Video tutorials are also available

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http://www.who.int/neglected_diseases/preventive_chemotherapy/reporting/en/

http://www.who.int/neglected_diseases/preventive_chemotherapy/reporting/fr/

http://www.who.int/neglected_diseases/preventive_chemotherapy/reporting/es/

http://apps.who.int/iris/bitstream/10665/83962/1/9789241505499_eng.pdf?ua=1




Managing Drug Flow is Almost Managing the Whole Programme

Step 1

• Annual work planning

• Drug forecast

• Drug request (including treatment planning)

• Drug supply

Step 2

• Drug distribution (PC) &

• Its related work (survey, M&E)

Step 3

• Treatment reporting

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Who should fill the JAP?

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JAP: Take Home Message

• Submission deadline is 15 August 2015 (at latest).– Requests can be accepted all year round but the earlier submitted the better (i.e. more timely

delivery of medicines)

– It will take at least 6 months between submission of the request and delivery

• The forms do not necessarily need to be submitted all together. You can submit whichever form as soon as they are completed.

• A bottom-up approach is recommended: MoHs fill the forms in coordination with partners, with the support of WHO COs/Ros. – Submission is by email: [email protected]

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PART 2. DRUG SUPPLY CHAIN (DSC) MANAGEMENT

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Objectives of Drug SCM System

• To provide the correct quantity of PC drugs.

• To provide the correct quality of PC drugs.

• To the correct location (where needed and most strategic).

• At the correct time (in time for treatment, no stock outs or overstocks).

• At the lowest possible cost.

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Preparing for Shipment

Adapted from Zithromax in the Elimination of Blinding Trachoma. Program Manager’s Guide. International Trachoma Initiative, 2010.

Green Light Check List

CommunicationAre the customs agents aware of the shipment and the quantities of the shipment?

Yes/No

Customs Clearance Waiver

Has the customs clearance duty waiver been prepared? Yes/No

Customs Duty Is the money ready to pay for duty for the inbound shipment? Yes/No

Warehouse SpaceDoes the central medical store have space to receive the shipment?

Yes/No

Distribution Is the program prepared to distribute the drugs? Yes/No

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Receipt and Inspection

• Inspect the shipment and give feedback to suppliers and the donation programmeon compliance to contract or donation specifications. – Quantity-damaged or short landed items included

– Drug Type

– Presentation

– Packaging and labeling

**Note some countries require pre-inspection before shipment.

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Port Clearance: Shipping Documents

• Certificate of Donation - Confirms source, authenticity, sent by donation program.

• Pro Forma Invoice - confirms quantities, source of products shipped, sent by supplier/donation program prior to shipment, used for application for duty waivers, ex and taxes exemptions. It can also be used for Drug Regulatory Authority approvals.

• Invoice - final document provided by the shipper stating costs, freight, insurance.

• Certification of Analysis - it is usual practice for a buyer to insist on certification. Usually NTD programs are WHO pre-qualified.

• Certificate of Origin- documents stating that the products were produced by the manufacturer stated.

• Airway Bill, Packing List, Bill of Laden - issued by the shipper, indicates which vessel (by air or by sea), date of departure and arrival. Originals accompany goods, but copies are scanned and sent to NTDPs prior to arrival of goods to be used to alert clearing agent of Expected Date of Arrival (EDA).

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Examples of Poor Storage

• Inadequate storage space and organization for drugs and laboratory products.

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Photos provided by Management Sciences for Health




Examples of Poor Storage

• Poor storage conditions for pharmaceutical and laboratory products.

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Examples of Good Storage

• Inventory management can be conducted with ease and bin cards can be affixed to the shelves.

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Borrowed from Zithromax in the Elimination of Blinding Trachoma. Program Manager’s Guide. International Trachoma Initiative, 2010.

Distribution Plan

• Should be based on schedule of drug distribution at the district level.

• Communications with storage facilities to ensure adequate capacity & supply.

• All districts must receive full supply at least 2-3 weeks before distribution begins.

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Shelf Life

ALB, MBD 60 months

IVM, DEC 36 months

PZQ 24 months

AZM tablets 48 months

AZM pediatric oral suspension(before reconstitution)

36 months

AZM pediatric oral suspension(after reconstitution)

10 days

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Why do drugs sometimes expire at the national, subnational or district levels?

How can we avoid this?

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MDA and Village Health Volunteers (VHV)s

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MDAs in Sierra Leone. Photos provided by HKI




SCENARIO A

Community-based distribution

• Drugs have arrived (when and where)

• Distributors are trained and ready

• Communities are informed and come for treatment

• MDA takes place

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What are the key concerns regarding the PC drugs at this point, for you as a NTDP Manager?

31




Drug SCM and Logistics

• What stock transfer strategies could be employed?

• Are there alert systems that can be put in place?

• How do you retrieve and account for unused stock after the MDA?

• Are there logistics concerns for other supplies needed for the MDA?

32




What information needs to be collected aspart of the treatment intervention –

specific to drug SCM?

33




Record Keeping and Information Reporting

• Should include: – # drugs at the beginning of the treatment

– # drugs used for treatment

– # drugs wasted

– # drugs expired

– # drugs remaining at the end of the treatment

34




Who is responsible for this information collection and how does it return to you as a

Programme Manager?

35




Drug SCM at the Point of Distribution

• Key concerns: – Drug is given in correct dose to persons in need

– Exclusion criteria are understood by CDDs and communities

• Who is responsible?

• CDDs must give the right information.

• CDDs must do the right thing so as to ↓ the chances of AE/SAEs.

• CDDs should be able to recognize and give appropriate initial management/referral for SAEs.

• Children are not forced to swallow tablets and risk choking.

• Children are not taking tablets when hungry or dehydrated.

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Dosage and Exclusion Criteria

Drug Dosage Exclusion Criteria

IVM 150-200 μg/kg

using tablet pole•1 tablet•2 tablets•3 tablets•4 tablets

•90-120cm (35-47”)•120-141cm (47-55”)•141-159cm (55-63”)•>159cm (>63”)

• <5 years of age• Pregnant women• Severely ill• <1week postpartum mothersIVM where Loa loa is endemic, assessed by

RAPLOA is justified only when onchoprevalence is >40%

DEC 6mg/kg or by age•100 mg•200 mg•300 mg

•2-5 years of age•6-15 years of age•>15 years of age

• Sick individuals• <2 years of age• Pregnant women• DEC is contraindicated in areas where

oncho and loiasis might co-exist

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Dosage and Exclusion Criteria

Drug Dosage Exclusion Criteria

ALB One 400 mg tablet per person < 2 years of agePregnant women in 1st trimester

MBD One 500 mg tablet per person <1 year of agePregnant women in 1st trimester

PZQ 40 mg/kg using pole600 mg tablets•1 tablet•1 1/2 tablets•2 tablets•2 1/2 tablets•3 tablets•4 tablets•5 tablets

• 94-110cm (37-43”)• 110-125cm (43-49”)• 125-138cm (49-54“)• 138-150cm(54-59“)• 150-160cm(59-63“)• 160-178cm(63-70“)• >178cm(70“)

<4 years of age

AZM 20mg/kg using dose pole 250 mg tablets <6 months of age

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Tools for the Drug Distributor

• Standardized Height-Based Treatment Schedule for azithromycin POS and tablets for Trachoma.

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Looking at all the components of the distribution cycle, what are the areas where monitoring and supervision is most critical?

40




NTD Drug SCM Cycle

41




What are the key messages from this session?

42




Key Messages

• By understanding SCM and issues that can delay or interrupt it, NTD PMs can better plan and implement effective MDA.

• A detailed Distribution and Transportation Plan is an essential part of SCM.

• As the last point of drug SCM and the primary point of contact with the community, CDDs play a critical role in distribution and reporting.

• Effective CDD training, job aids, support, and supervision should be provided.

• Respect the season of availability of CDDs and communities to participate in MDA.

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Thank you

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